TOES Evaluations of Abstracts Submitted for the 69th Annual Scientific Meeting of the American College of Gastroenterology
American Journal of Gastroenterology, Vol. 99, No. 10, Suppl., 2004, ©2004 by Am. Coll. of Gastroenterology, ISSN 0002-9270/04/xx.xx, Published by Blackwell Publishing
October 29–November 3, 2004, Orlando, Florida
SAFETY AND PHARMACODYNAMICS OF 2- AND 3-MINUTE INJECTIONS OF INTRAVENOUS LANSOPRAZOLE
Chang Lee, M.D., Cong Han ∗ . TAP Pharmaceutical Products Inc. Am J Gastro 2004:99 Suppl; A103.
Evidence-based info : Restrospective review of selected data from various prospective studies.
Type of Study : Marketing study
Sample size : n = 76
Background : Are 2 or 3 minute bolus infusions of i.v. lansoprazole 30 mg safe? What kind of pH control (meaning time > pH 4) can be achieved in Japanese patients?
Primary finding : 30% of patients had symptoms such as diarrhea, abdominal pain, headache, nausea, epistaxis, lacrimation, feeling that ear is closed.
Score of Study (TOES): = 25 out of 100
Is it consistent with what we already know? – Yes
How should this effect your practice?
- It shouldn't as these were Japanese patients. Japanese patients are far more likely to be SLOW metabolizers and generally produce less acid than Caucasian counterparts.
- It is important to note that even after 5 days of treatment with lansoprazole 30 mg i.v. the pH > 4 was only 53% of the time. Lansoprazole 30 mg i.v. b.i.d. produced a pH > 4 for approximately 65% of the 24 hr period.
- These data are similar to oral lansoprazole. Delayed-release PPI does not produce rapid pH control whether it is given i.v. or p.o.
- The pH control of interest is time pH > 6.2 in the first 4 hours as this reflects the ability to prevent rebleeding after upper GI bleed.